Home » Trials » SLCTR/2018/008


Conducting operational research to identify numbers and rates, determine needs, and integrate services to mitigate morbidity and mortality among internally displaced persons affected by emergencies -

SLCTR Registration Number

SLCTR/2018/008


Date of Registration

27 Feb 2018

The date of last modification

May 03, 2018



Application Summary


Scientific Title of Trial

Conducting operational research to identify numbers and rates, determine needs, and integrate services to mitigate morbidity and mortality among internally displaced persons affected by emergencies


Public Title of Trial

Integrating mental health into primary care for post-conflict populations in Northern Sri Lanka (COMGAP-S)


Disease or Health Condition(s) Studied

Mental disorders


Scientific Acronym

COMGAP-S (COnflict-affected Migrants mhGAP Study)


Public Acronym

COMGAP-S (COnflict-affected Migrants mhGAP Study)


Brief title

None


Universal Trial Number

U1111-1196-4127


Any other number(s) assigned to the trial and issuing authority

ISRCTN62598070; UK:Faculty Research Ethics Panel Faculty of Medical Science Anglia Ruskin University, 19/1/2017, ref:SC/jc/FMSFREP/16/17076; Sri Lanka:Ethics Review Committee Faculty of Medicine University of Jaffna, 4/1/2018, Ref:J/ERC/17/81/NDR/0170


Trial Details


What is the research question being addressed?

What are the changes in knowledge and skills on identification, treatment/management and referrals of mental disorders among primary care practitioners who have been trained to use a locally adapted version of the WHO mhGAPprogramme compared to existing standard of care?


Type of study

Interventional


Study design

Allocation

Non-randomized controlled trial


Masking

Masking not used


Control

Standard therapy


Assignment

Other


Purpose

Treatment


Phase


Intervention(s) planned

Study settings: 25 primary care facilities across all 5 districts of the Northern Province, Sri Lanka

Method of allocation: Multi-centre stepped wedge cluster randomised trial

Intervention

Primary care practitioners: Primary Care Practitioners (PCP) at randomly selected facilities will be monitored for 1 month prior to commencement of training. They will receive 3 days training, 6 hours a day, 1-on-1 training using locally adapted WHO mhGAP intervention guide. Once training is completed, PCPs will use the mhGAP guide to diagnose, treat and refer primary care patients with possible mental health problems.

Public health professionals (PHPs): 2 days training in groups of 3, 6 hours a day using locally adapted educational material on mental health awareness and stigma reduction. Once training is completed, PHPs will engage in specific activities outlined during their training with the patient population attending their respective facilities.

Community representatives (CRs): 1 day training in groups of 2 or more, 6 hours total, using locally adapted educational material on mental health awareness and stigma reduction. Community Representatives (CR) will not be randomized. CR within the catchment area of each randomly selected primary care facility will be identified and approached for inclusion. Once training is completed, CRs will engage in specific activities outlined in their training within their respective communities such as creating awareness, finding local resources and organizing mental health promotional activities.

Patients attending primary care facilities who are identified by mhGAP trained primary care practitioners will be asked to answer a brief socio-demographic questionnaire at point of recruitment along with the Hopkins Symptoms Checklist (for depression and anxiety) at point of recruitment and at 3 and 6 months follow up. They will also be re-examined by a psychiatrist to confirm the primary care practitioner diagnosis.

All training interventions will be based on the World Health Organization mhGAP 2.0 training module. Key modules informed by previous work on depression, stress related disorders, medically unexplained symptoms, alcohol/drug use disorder, and others will be used. All materials have been locally translated and adapted.

After training is completed PCPs, PCPs and CRs will be monitored for a period of 1 month.

Pre- and post-knowledge tests and refresher courses will be carried out at 3 and 6 months after initial training.

PCPs, PHPs, CRs who haven’t yet received training, and their patients will act as controls and will continue treatment as usual.


Inclusion criteria

Primary Care Practitioners (PCP)
1. Full registration with the Sri Lankan Medical Council
2. At least 6 months or more until their next transfer rotation (this applies only for PCP working in government facilities) or 6 months to retirement

Public Health Personnel (PHP)
1. Nurse, attendant or health service assistant within each facility
2. At least 6 months left on their transfer rotation (this applies only for PHP working in government facilities) or 6 months to retirement

Community Representatives (CR)
1. Located within the catchment area of each selected facility

Patients
1. Aged 18 years or older
2. Attend selected facilities
3. Belong to IDP or post-conflict populations


Exclusion criteria

Primary care practitioners, public health professionals and community representatives will be excluded if they have secondary mental health training. Patients will be excluded if they are under 18 years or diagnosed with mental disorders other than depression and/or anxiety.



Primary outcome(s)

  1. Successful uptake of mhGAP 2.0 training is measured using minimum 40% concurrence increase of primary care practitioners who correctly diagnose patients with common mental disorders as verified by specialist psychiatrists.

    [

    1 month after completion of mhGAP 2.0 training

    ]

Secondary outcome(s)

  1. Successful integration of mental health services into primary care is measured by reaching a 40% rate of mhGAP 2.0 trained primary care practitioners in the Northern Province at 1 year.

    [

    1 year after completion of mhGAP 2.0 training

    ]

Target number/sample size

25 facilities (cluster): 25 PCPs total, 1 in each cluster; 75 PHPs total, 3 in each cluster; 50 CRs total, 2 in each cluster; 200 patients total, 8 in each facility


Countries of recruitment

Sri Lanka


Anticipated start date

2018-03-13


Anticipated end date

2018-03-13


Date of first enrollment


Date of study completion


Recruitment status

Recruiting


Funding source

Centers for Disease Control and Prevention, United States of America (Cooperative Grant Number 1U01GH001654)



State of Ethics Review Approval


Status


Date of Approval


Approval number


Details of Ethics Review Committee

Name:
Institutional Address:
Telephone:
Email:


Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Shannon Doherty
Principal Investigator
Bishop Hall Lane Chelmsford, United Kingdom CM1 1SQ
Tel: +448451963154
Mob: +447522128409

shannon.doherty@anglia.ac.uk
globalhme.org

Contact Person for Public Queries

Ms. Giselle Dass
Senior Research Associate
THEME Institute 81/7, Pagoda Road Nugegoda Colombo
Tel: +94 11 7446919


giss.dass@gmail.com
globalhme.org


Primary study sponsor/organization

Anglia Ruskin University
Primary study organization
Bishop Hall Lane Chelmsford, United Kingdom CM1 1SQ



http://www.anglia.ac.uk/medical-science

Secondary study sponsor (If any)

THEME Institute
Secondary study organization
49/c/3 Gemunu Mawatha Athurugiriya, Sri Lanka
Tel: +94117446919

themeinstitute.sl@gmail.com

Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description


Study protocol available


Protocol version and date


Protocol URL


Results summary available


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results